ibuprofen

Generic: ibuprofen

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler sun pharmaceutical industries, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1385
Product ID 51672-1385_46f3c164-da78-0045-e063-6294a90a6885
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209204
Listing Expiration 2026-12-31
Marketing Start 2017-06-23

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721385
Hyphenated Format 51672-1385

Supplemental Identifiers

RxCUI
197803
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA209204 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-1385-8) / 118 mL in 1 BOTTLE
  • 473 mL in 1 BOTTLE (51672-1385-9)
source: ndc

Packages (2)

51672-1385-8 1 BOTTLE in 1 CARTON (51672-1385-8) / 118 mL in 1 BOTTLE 51672-1385-9 473 mL in 1 BOTTLE (51672-1385-9)

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46f3c164-da78-0045-e063-6294a90a6885", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["a8b46ae5-67bc-494d-850e-b4e4ed5a33b3"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1385-8)  / 118 mL in 1 BOTTLE", "package_ndc": "51672-1385-8", "marketing_start_date": "20170623"}, {"sample": false, "description": "473 mL in 1 BOTTLE (51672-1385-9)", "package_ndc": "51672-1385-9", "marketing_start_date": "20170623"}], "brand_name": "Ibuprofen", "product_id": "51672-1385_46f3c164-da78-0045-e063-6294a90a6885", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "51672-1385", "generic_name": "Ibuprofen", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA209204", "marketing_category": "ANDA", "marketing_start_date": "20170623", "listing_expiration_date": "20261231"}